Relaxation Guided Imagery for Treatment of Pain in Parkinson's Disease

November 5, 2014 updated by: Dr. Ilana Schlesinger, Rambam Health Care Campus

Pilot Study of Relaxation Guided Imagery for Treatment of Pain in Parkinson's Disease

Parkinson's disease patients may have severe non-motor symptoms. A common and troublesome non-motor symptom is pain. Currently these symptoms are treated with medication with limited success. Our study aims to determine whether relaxation guided imagery can alleviate pain in Parkinson's disease patients.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Parkinson's disease patients with severe pain without dementia will participate in this study aimed to examine a possible beneficial effect of relaxation guided imagery on pain. This will be a phase I, controlled, single blind and randomized efficacy study in 2 parallel groups. The study will include a baseline assessment of pain severity where after the intervention group will undergo relaxation guided imagery and the control group will listen to relaxing music. After these relaxation session patients will receive a CD with either relaxation guided imagery or relaxing music to listen to at home. Pain severity will be recorded for the following 6 weeks.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with idiopathic Parkinson's disease suffering from significant pain.

Exclusion Criteria:

  • Dementia
  • Hearing impairment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Relaxation guided imagery
Behavioral: Relaxation guided imagery
An individualized relaxation guided imagery session will be conducted. After the session patients will be given a CD with the relaxation guided imagery and asked to listen to it at home.
Active Comparator: Relaxing music
Behavioral: Relaxing music
An individualized session of listening to relaxing music will be conducted. After the session patients will be given a CD with the relaxing music and asked to listen to it at home.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain scores on the visual analog scale
Time Frame: 6 weeks
Numeric rating scale after relaxation guided imagery as compared with baseline
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The brief Pain Inventory
Time Frame: 6 weeks
The brief Pain Inventory after relaxation guided imagery as compared with baseline
6 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Health status measured by Parkinson's Disease Questionnaire 39(PDQ39)
Time Frame: 6 weeks
PDQ39 after relaxation guided imagery as compared with baseline
6 weeks
Depression scores on Beck Depression Inventory (BDI)
Time Frame: 6 weeeks
BDI after relaxation guided imagery as compared with baseline
6 weeeks
Non-motor symptom screening questionaire
Time Frame: 6 weeks
Non-motor symptom screening questionaire after relaxation guided imagery as compared with baseline
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rambam Health Care Campus

Investigators

  • Principal Investigator: Ilana Schlesinger, M.D., Rambam Health Care Campus, Haifa, Israel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

May 19, 2013

First Submitted That Met QC Criteria

May 29, 2013

First Posted (Estimate)

May 30, 2013

Study Record Updates

Last Update Posted (Estimate)

November 6, 2014

Last Update Submitted That Met QC Criteria

November 5, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0494-12

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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